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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01100502
Other study ID # SGN35-005
Secondary ID 2009-016947-20
Status Completed
Phase Phase 3
First received
Last updated
Start date April 30, 2010
Est. completion date April 27, 2020

Study information

Verified date April 2021
Source Seagen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


Recruitment information / eligibility

Status Completed
Enrollment 329
Est. completion date April 27, 2020
Est. primary completion date August 31, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with HL who have received ASCT in the previous 30-45 days - Patients at high risk of residual HL post ASCT - Histologically-confirmed HL - ECOG of 0 or 1 - Adequate organ function Exclusion Criteria: - Previous treatment with brentuximab vedotin - Previously received an allogeneic transplant - Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT - History of another primary malignancy that has not been in remission for at least 3 years - Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
placebo
Every 21 days by IV infusion

Locations

Country Name City State
Bulgaria Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno Sofia
Bulgaria Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania Sofia
Czechia Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie Hradec Kralove
Czechia Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie Praha
Czechia Vseobecni fakultni nemocnice v Prahe-I. interni klinika Praha
France CHU Nantes - Hopital Hotel Dieu Service Hematologie Nantes
France Service des Maladies du Sang / Hospital Saint Louis Paris
France CHU Bordeaux Hopital Haut-Levaque Pessac
France Centre Hospitalier Lyon Sud Pierre Benite
France Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer Rouen
Germany University Hospital of Cologne Koeln
Hungary Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly Budapest
Hungary Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika Debrecen
Hungary Medical Center of the University of Pecs, 1st Clinic for Internal Medicine Pecs
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont Szeged
Italy Instituto di Ematologia ed Oncologia Medica Bologna
Italy Azienda Ospedaliera Universitaria San Martino Genova
Italy Istituto Nazionale dei Tumori Milano
Poland Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne Gdansk
Poland Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach Gliwice
Poland Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego Katowice
Poland Szpital Uniwersytecki w Krakowie Krakow
Poland Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Lodz
Poland Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Lublin
Poland Centrum Onkologii Institut im. Marii Sklodowskiej-Curie Warsaw
Poland Klinika Hematologii, Instytut Hematologii i Transfuzjologii Warsaw
Poland MTZ Clinical Research Sp. z o.o. Warsaw
Romania Fundeni Clinical Institute Bucharest
Romania Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu Bucharest
Romania Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular Targu Mures Judetul Mures
Romania Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie Timisoara Judetul Timis
Russian Federation Burdenko Central Military Clinical Hospital Moscow
Russian Federation Federal Medical Biophysical Center n.a. A.I. Burnazyan Moscow
Russian Federation Gematologicheskj nauchnyj centr RAMN Moscow
Russian Federation Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN Moscow
Russian Federation Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii Novosibirsk
Russian Federation Respublikanskaja bol'nica im. V.A. Baranova Petrozavodsk
Russian Federation Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High St. Petersburg
Russian Federation Gorodskaya bol'nica #31 St. Petersburg
Russian Federation Leningradskaja oblastnaja klinicheskaja bol'nica St. Petersburg
Russian Federation Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova St. Petersburg
Russian Federation St. Petersburg Pavlov State Medical University St. Petersburg
Russian Federation Sverdlovskaja oblastnaja klinicheskaja bol'nica #1 Yekaterinburg
Serbia Klinicki centar Srbije, Klinika za hematologiju Belgrad
Serbia Vojnomedicinska akademija, Klinika za hematologiju Belgrad
Serbia Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju Novi Sad
Spain Hospital Clinic i Provincial Servicio Hematologia Barcelona
Spain Hospital de la Santa Creu i Sant Paul Barcelona
Spain Centro Oncologico MD Anderson Madrid
Spain Complejo Hospitalano de Navarra Servicio Hematologia Pamplona Navarra
Spain Hospital Universitaro de Salamanca Salamanca
United Kingdom Addenbrooke's Hospital Cambridge
United Kingdom St James University Hospital Leeds
United Kingdom Guy's Hospital Haematology Department, 4th Floor Southwark Wing London
United Kingdom Christie Hospital NHS Foundation Trust Manchester
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Northside Hospital Atlanta Georgia
United States Johns Hopkins Medical Center Baltimore Maryland
United States Dana Farber Cancer Institute Boston Massachusetts
United States UNC Lineberger Comprehensive Cancer Center / University of North Carolina Chapel Hill North Carolina
United States Northwestern University Chicago Illinois
United States University of Chicago Section of Hematology/Oncology Lymphoma Program Chicago Illinois
United States Cleveland Clinic, The Cleveland Ohio
United States James Cancer Hospital / Ohio State University Columbus Ohio
United States Baylor University Medical Center Dallas Texas
United States Colorado Blood Cancer Institute Denver Colorado
United States Karmanos Cancer Institute / Wayne State University Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Cancer Center of the Carolinas Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States MD Anderson Cancer Center / University of Texas Houston Texas
United States Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380 Indianapolis Indiana
United States Cardinal Bernardin Cancer Center / Loyola University Medical Center Maywood Illinois
United States University of Minnesota Minneapolis Minnesota
United States Memorial Sloan Kettering Cancer Center New York New York
United States New York University Cancer Institute New York New York
United States Temple Bone Marrow Transplant Program Philadelphia Pennsylvania
United States Western Pennsylvania Cancer Institute Pittsburgh Pennsylvania
United States Oregon Health and Science University / Center for Hematologic Malignancies Portland Oregon
United States Virginia Commonwealth University Medical Center Richmond Virginia
United States University of Rochester Medical Center Rochester New York
United States Washington University School of Medicine Saint Louis Missouri
United States University of California at San Francisco San Francisco California
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Stanford Cancer Center Stanford California
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Seagen Inc. Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  France,  Germany,  Hungary,  Italy,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

References & Publications (1)

Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival by Independent Review Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first Up to approximately 4 years
Secondary Overall Survival Time from date of randomization to date of death due to any cause Up to approximately 10 years
Secondary Incidence of Adverse Events or Laboratory Abnormalities Up to 12 months
Secondary Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin Up to 12 months
See also
  Status Clinical Trial Phase
Completed NCT00430846 - Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies Phase 1
Terminated NCT00649584 - A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies Phase 1
Completed NCT00947856 - A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study Phase 2
Completed NCT01026233 - Cardiac Safety Study of Brentuximab Vedotin (SGN-35) Phase 1
Completed NCT01060904 - A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma Phase 1
Completed NCT00848926 - A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma Phase 2
Completed NCT01026415 - Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) Phase 1
No longer available NCT01196208 - A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001